MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number 309.530

Device Problems Break (1069); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for, and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during lcp proximal tibia plate removal surgery, the spare reamer tube, extraction bolt, and conical extraction screw were broken and nonfunctional.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed using other instruments.There was no patient consequence.This report is for one (1) conical extraction screw for large screws & 4.9mm bolts.This is report 3 of 3 for (b)(4).

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.D4, d9: complained device is no longer expected to be returned for investigation.H3, h4, h6: part 309.530, lot 22p9040: manufacturing site: bettlach.Release to warehouse date: december 12, 2019.A manufacturing record evaluation was performed for the finished device 309.530, lot: 22p9040 and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.H10 additional narrative: d4.Lot.D9.Date device returned to manufacturer.H6 - codes updated to imdrf codes.Visual inspection: the extract-screw coni f/scr ø4.5+6.5 was returned for analysis.Visual inspection of the returned device found a broken condition, one of the fragments was received in the package.Deformed condition cannot be confirmed.Additionally, during physical evaluation corrosion was identified on different areas of the device.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Investigation conclusion: the reported condition of the complaint device (extract-screw coni f/scr ø4.5+6.5) is confirmed.Device is broken.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - 01/26/2022 part: 309.530 lot: 3l53625 manufacturing site: selzach supplier: synthes gmbh release to warehouse date: 13 may 2019 expiration date: n/a a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 309.530 lot: 22p9040 manufacturing site: bettlach release to warehouse date: 12.12.2019 a manufacturing record evaluation was performed for the finished device 309.530, lot: 22p9040 and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10831604
• MDR Text Key: 216145548
• Report Number: 8030965-2020-08905
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819018457
• UDI-Public: (01)07611819018457
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 309.530
• Device Lot Number: 3L53625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 01/05/2021; 02/09/2022
• Supplement Dates FDA Received: 01/06/2021; 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXTRACT-BOLT F/SCR Ø4.5+5; SPAREREAMERTUBE F/309.450