MAUDE Adverse Event Report: SYNTHES GMBH EXTRACT-INSTR F/TFNA HELIC BLADE+SCR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 03.037.030

Device Problem Device-Device Incompatibility (2919)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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)(64) as follows: it was reported that on (b)(6), 2021 an adverse event was presented in the room, where the material was extracted and the screw did not hold to perform the procedure.As a result the procedure, and prolonged anesthesia time for the patient.Concomitant medical products: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) extract-instr f/tfna helic blade+scr.This is report 1 of 1 for complaint (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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the photos received.The images were reviewed, and the complaint condition is not confirmed.The device does not appear to have any defect that would prevent assembly.As the physical device was not received, a functional test could not be performed and therefore it is impossible to know if the device is unable to assemble with the screw.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.No dhr review was completed since no lot number was supplied via photo or additional information.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.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.H3, h4, h6: part: 03.037.030, lot: 9769914, manufacturing site: hagendorf, supplier: n/a, release to warehouse date: march 21, 2016, expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the extract-instr f/tfna helic blade+scr (part# 03.037.030, lot# 9769914) was returned and received at us customer quality (cq).Upon visual inspection at cq, it is observed that the distal tip of the device was stripped/ worn out.No other issues were observed with the complaint device.Functional test: a functional assessment was not performed on the complaint device since device was returned by itself.The screw was not returned.However, the stripped condition of the device could have contributed to the complaint condition.Can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: feature: shaft diameter near tip result: conforming measurement device: caliper.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed extraction instrument for head element no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed as the distal tip of the device was stripped/worn out.The potential cause for the device interaction condition could be due to stripped tip.No definitive root cause could be determined based on the provided information.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: EXTRACT-INSTR F/TFNA HELIC BLADE+SCR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12658887
• MDR Text Key: 281660735
• Report Number: 8030965-2021-08790
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642560
• UDI-Public: (01)07611819642560
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131548
• 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
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.030
• Device Lot Number: 9769914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• 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: UNK - SCREWS: TRAUMA