MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/90MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 280.29

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Part #: 280.29 lot #: 6533836 manufacturing site: (b)(4), supplier: synthes usa hq, inc, release to warehouse date: 29 nov 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the dhs/dcs-scr ø12.5 l90 octagonal-coupl ss (part #: 280.29, lot #: 6533836) was received at us customer quality (cq).Visual inspection showed that the device was severely scratched and nicked.It was also observed to be slightly deformed at the proximal end around the hole.Functional test: during functional assessment, the device was assembled with its mating device (the second returned device).Both devices stuck together but after wiggling and pulling in opposite directions both devices; they came apart; hence this complaint is confirmed.Can the complaint be replicated with the returned device? yes.Dimensional inspection: measured dimensions, flat diameter: conform, round diameter: conform.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device was severely scratched and nicked.It was also observed to be slightly deformed at the proximal end around the hole.This condition of the device contributed to the reported condition of jammed/seized.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the dhs wrench still had a dhs implant from the previous case stuck on the wrench.The jammed lag screw was removed from the wrench so that the wrench could be used to remove the dhs screw in the patient on the table.The primary implantation happened couple of years ago.The bone had united well.There is no allegation against the implants.The patient experienced slight soft tissue irritation (no infection ) which was very common and opted to remove the implants (dhs dynamic hip screw) and 7.3mm cannulated screw) on (b)(6) 2021.The implants were intact after removal.There was no adverse event to patient.There was no surgical delay.This report is for one (1) dhs/dcs one-step lag screw 12.7mm thread/90mm.This is report 1 of 1 for (b)(4).

• Brand Name: DHS/DCS ONE-STEP LAG SCREW 12.7MM THREAD/90MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12543678
• MDR Text Key: 273785469
• Report Number: 8030965-2021-08102
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K964259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.29
• Device Lot Number: 6533836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1