MAUDE Adverse Event Report: SYNTHES GMBH TI DHS/DCS LAG SCREW 12.7MM THREAD/105MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.050S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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 an unknown date, the customer received the incorrect product.The customer received a product that indicated a length of 105mm on the packaging but there was a length of 125mm indicated on the delivery form.There is no further information available.This report is for one (1) ti dhs®/dcs® lag screw 12.7mm thread/105mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.D10: complainant part returned for manufacturer review/investigation.D11: updated concomitant products provided for reporting.H3, h6: the subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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.Investigation selection investigation site: cq zuchwil, selected flow(s): labeling & packaging.Visual inspection: upon visual inspection of the complaint device it can be seen that the implant got returned in the original packaging, the packed implant (still sterile in first and second sterile bag) matches with the label.Additionally the packing is showing two damage, one corner is slight torn open and the other corner has a pressure mark, otherwise is the packing in a good condition.Summary: based on the complaint description we have scanned (read out) the label together with the labeling department and can confirm that the value matches the label.As we are not able to confirm or reproduce the reported occurrence, the complaint is not confirmed.The visible damage mentioned before has to be a result of transport and storage, as such damage would be noticed during the final inspection.Based on this the complaint is confirmed, but no manufacturing related issue was identified and/or confirmed.The cause of complained malfunction is a post-manufacturing caused and/or use related, therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot sterile part: part number: 480.050s, lot number: 6l72075, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 21.Feb.2020, expiry date: 01.Feb.2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: part: 480.050, lot: 36p8757, manufacturing site: balsthal, release to warehouse date: 24.January 2020.A manufacturing record evaluation was performed for the finished device lot number 36p8757 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: TI DHS/DCS LAG SCREW 12.7MM THREAD/105MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10671991
• MDR Text Key: 212327423
• Report Number: 8030965-2020-07876
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819275324
• UDI-Public: (01)07611819275324
• Combination Product (y/n): N
• PMA/PMN Number: K953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

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: 480.050S
• Device Lot Number: 6L72075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 10/14/2020; 11/13/2020
• Supplement Dates FDA Received: 11/09/2020; 12/09/2020
• Patient Sequence Number: 1
• Treatment: DHS/DCS-SCR L105 TAN; DHS/DCS-SCR L105 TAN; DHS/DCS-SCR L105 TAN