MAUDE Adverse Event Report: SYNTHES GMBH BALL SPIK STRAIG W/POINTED BALL TIPS Ø6.; RETRACTOR

Catalog Number	03.100.018
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported multiple devices are no longer functional.These issues did not impact patient outcomes.Below devices were found to be "release mechanism broken" during inspection: 03.043.028.Below devices were found to be "stripped threads" during inspection: 03.120.022, 312.648, 323.029.Below devices were found to be "nut stuck on sleeve" during inspection: 03.037.017, 03.037.016.Below devices were found to be "handle leaching/spd wil not sterilize" during inspection: 03.100.018.Below devices were found to be "broken handle" during inspection: 311.43.Below devices were found to be "stripped drill connection and 2nd is cold welded to a schanz pin" during inspection: 393.103.Below devices were found to be "broken sliding mechanism" during inspection: 319.091.Below devices were found to be "not snapping in" during inspection: 03.120.018, 03.120.017.Below devices were found to be "stripped" during inspection: 03.010.151, 314.467, 03.900.042, 03.130.010, 314.453, 03.010.150, 03.010.152.Below devices were found to be "not working properly" during inspection: 329.15.Below devices were found to be "not locking tension between trigger pulls" during inspection: 03.221.015.Below devices were found to be "not aligned" during inspection: 398.65.Below devices were found to be "not locking into aiming arm" during inspection: 03.231.007.Below devices were found to be "bent handle" during inspection: 393.1.Below devices were found to be "trigger detached from handle" during inspection: 03.221.007.Below devices were found to be "not sliding properly" during inspection: 319.006.Below devices were found to be "shaft pulls out of handle" during inspection: 314.118.Below devices were found to be "not locking on" during inspection: 351.16j.Below devices were found to be "binding on qc attachments" during inspection: 511.773.Below devices were found to be "ends not aligning" during inspection: 03.221.011.(b)(4) is the mother complaint.(b)(4) are related to each other and are created to capture additional ips.
Additional Manufacturer Narrative
Pro dproduct complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d4 lot, d9.Corrected: d4 primary udi number, g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found foreign substance was not identified.However the handle was observed with orange spots near the two pin indicating a possible corrosion.The reported condition can be confirmed.Potential cause can be traced to maintenance, refer to the device/country specific ifu for information related to cleaning, sterilization, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the ball spik straig w/pointed ball tips ø6.Would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part number: 03.100.025, lot number: a70a25, manufacturing site: tuttlingen, release to warehouse date: week 25, 2005.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument.Information retrieved from (b)(4) as the impacted products share the same lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: b5, d10 (concomitant).Corrected: h8.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received: a.Date of event (if available): - items identified at various times in preop testing over the last few months.B.What is the timing of the reported event? (pre-op, intra-op, post-op) - pre-op.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d10.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BALL SPIK STRAIG W/POINTED BALL TIPS Ø6.
• Common Device Name: RETRACTOR
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO ; GM
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24179635
• Report Number: 8030965-2026-00875
• Device Sequence Number: 18531118
• Product Code: GAD
• UDI-Device Identifier: 10886982070678
• UDI-Public: (01)10886982070678(10)A70A25
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.100.018
• Device Lot Number: A70A25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/24/2026; 03/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/02/2026; 02/26/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CABLE TENSIONER ONE-H+OPERABLE.; CERCL-PASSER Ø60 MIN-INVASIVE.; DEPTH GAUGE F/CORTSCR Ø3.5 MEAS-RANGE UP.; FLEX SFT CONNECTOR FOR USE JACOBS CHUCK.; FORCEPS FOR BROKEN SCREW REMOVAL.; GUIDE SLEEVE F/AIMING ARM INSTR F/VA-LCP.; HANDLE WITH QUICK COUPLING, LENGTH 110 MM.; TORQUE LIMITER 1.5NM F/AO/ASIF.; UNIV-CHUCK W/T-HANDLE.
• Patient Sex: Unknown