MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE

Catalog Number 04.211.022S

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Device is not distributed in the united states, but is similar to device marketed in the usa.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) 2022, the patient underwent the first metatarsophalangeal (mtp) joint arthrodesis with the va-lcp mtp fusion plate for the hallux valgus correction.The surgeon proceeded with the surgery according to the surgical technique manual.The drill sleeve was inserted into the plate hole without difficulty, and drilling was performed without resistance.When the surgeon was inserting the va locking screw, he used a power tool to insert the screw halfway.Next, the surgeon used a screwdriver to insert the screw at the end.Although the surgeon inserted the va locking screw 2.7mm into the screw hole, the va locking screw spun without tightening.Therefore, the surgeon substituted a cortex screw and fixed.This event occurred at two screw holes on the plate in question.The surgery was completed successfully within 30 minutes delay.Patient was listed as stable.This is report 3 of 3 for (b)(4).This report is for 2.7 mm locking screw.

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.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: d9 d10 therapy date: march 15, 2022.H3, h6: part # 04.211.022s.Lot # 8l20038.Release to warehouse date: 25 may 2021.Expiration date: 01 may 2031.Supplier: (b)(4).Non-sterile part # 04.211.022.Lot # 112p171.Manufacturing location: monument.Manufacturing date: 22-apr-2021.Part number: 04.211.022, 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 22mm lot number: 112p171 (non-sterile).Six pieces were scrapped turn/thread head, flute, after a robot misload.Production order traveler met all inspection acceptance criteria apart from the six pieces noted.Inspection sheet, in process / inspect dimensional / final inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿screw spun in plate without tightening¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the va lockscr ø2.7 head 2.4 self-tap l22 ta.A dimensional inspection was performed for the va lockscr ø2.7 head 2.4 self-tap l22 ta and met specifications.A functional test and could not be performed as the mating devices were not returned.However, the assembly issues could be not confirmed due to not observed damage or defects with the va lockscr ø2.7 head 2.4 self-tap l22 ta.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the va lockscr ø2.7 head 2.4 self-tap l22 ta.Was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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 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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14091016
• MDR Text Key: 289201221
• Report Number: 8030965-2022-02391
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819444171
• UDI-Public: (01)07611819444171
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.022S
• Device Lot Number: 8L20038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1ST MTP FUSION PL 2.4/2.7 VA LOCK SM L42; 1ST MTP FUSION PL 2.4/2.7 VA LOCK SM L42; UNK - DRILL BITS; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - POWER TOOL; UNK - SCREWDRIVERS: TRAUMA; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Sex: Female