MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 6.5MM CANNULATED SCREW 32MM THREAD 95MM; SCREW, FIXATION, BONE

Catalog Number 208.441S

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review / investigation.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 the cannulated screw (sterile packed) opened at request of surgeon.He was unable to pass the screw over the guide wire.Upon inspection the cannulation was blocked with some metal reamings / shavings.Attached is pictures of the screw, and of the product code and lot number.Unfortunately, the scrub staff disposed of the screw before i was able to recover it.Concomitant devices reported: cortscr ø3.5 self-tap l40 sst (part# 204.840s, lot # 3l15519, quantity 1).Unk - guides / sleeves / aiming: sleeve (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 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.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.Picture review: the received picture confirm the issue as per event description; the complaint therefore has been determined to be confirmed.The received picture of an complained cannulated screw was forwarded to the manufacturing side for a statement.The statement below is a summary of their investigation.The device was not sent back by the customer.We just receive photos.On picture 1, we can see that the screw is damaged at the head of the screw.The laser marking is not readable on the screw throw the picture but could be sent by the customer and can be checked throw the picture of the packaging.As the device was not sent back, we are not able to perform the functional test.A manufacturing record evaluation was performed for the affected work order: 16589933, where no nonconformances, abnormalities nor deviations were identified which could lead to the complaint failure.In addition, the revision of the drawings of article 208.441 valid at the time of manufacturing, were reviewed and no relevant design changes were identified.As the device was not sent back, we are not able to perform measurements.The device was not sent back for investigation, we are unable to say if the complaint condition is confirmed with only pictures.As the complaint device was not sent back for investigation, just the dhr review was able to be performed.The conclusion of the dhr review show that there was no issue during the manufacturing process.Therefore, and as the manufacturing investigation was not completed performed, we cannot conclude if this complaint is confirmed.The complaint device would be required in order to perform the complete investigation.No more actions were taken.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.Steril - article, part: 208.441s, lot: 5l34480, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: july 11, 2019, expiry date: july 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-steril-article part: 208.441, lot: 4l58464, manufacturing site: grenchen, release to warehouse date: may 14, 2019.A manufacturing record evaluation was performed for the finished device lot number, 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: 6.5MM CANNULATED SCREW 32MM THREAD 95MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9120054
• MDR Text Key: 164462482
• Report Number: 8030965-2019-68700
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819750463
• UDI-Public: (01)07611819750463
• Combination Product (y/n): N
• PMA/PMN Number: K161616
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 208.441S
• Device Lot Number: 5L34480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Patient Sequence Number: 1
• Treatment: CORTSCR Ø3.5 SELF-TAP L40 SST; UNK - GUIDES/SLEEVES/AIMING: SLEEVE