MAUDE Adverse Event Report: SYNTHES GMBH 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.003.030

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional lot number provided: 80p4651.Initial reporter is a synthes sales representative.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that when the surgeon started to insert the first hip screw, it would not turn in the bone.The surgeon took it out and tried to insert it a second time, but it still would not go in.Another screw was used for the case.The procedure was successfully completed with a delayed of one hour.This report is for a hip screw.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part: 04.003.030s.Sterile lot: 7l81523.Manufacturing site: selzach.Supplier: früh verpackungstechnik ag.Release to warehouse date: 29 january 29, 2021.Expiration date: january 1, 2031.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile.Part: 04.003.030.Lot: 80p4651.Manufacturing site: mezzovico.Release to warehouse date: january 14, 2021.A manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Visual inspection: the hip scr ø6.5 self-tap l100 f/expert lfn (part #: 04.003.030s, lot #: 80p4651) was received at us customer quality (cq).Visual inspection of the complaint device showed scratches all over the device.The thread was also inspected and no issue could be observed.Functional test: a functional assessment was not performed with the complaint device since the applicable mating component(s) were not returned.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: specifications.Total length.Shaft od.Thread major od.Measured diameters.Total length = conform.Shaft od = conform.Thread major od = conform.Device used are hand micrometer and caliper.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no investigation conclusion: this complaint is not confirmed as there was no defect observed on the returned device that could have contribute to the reported allegation; however surface scratches were observed.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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.D1 d4: lot, catalog and udi.

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 100MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12448223
• MDR Text Key: 270612709
• Report Number: 8030965-2021-07608
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819802742
• UDI-Public: (01)07611819802742
• Combination Product (y/n): N
• PMA/PMN Number: K040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.003.030
• Device Lot Number: 80P4651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/10/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: FRN; UNK - SCREWDRIVERS; UNK - NAILS: FRN; UNK - SCREWDRIVERS
• Patient Age: 40 YR