MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TREPHINE ATTACHMENT 12.5MM DIAMETER

Catalog Number 387.662

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during an extraction of an iliac crest bone graft of the left side, that the tooth of the trephine attachment 12.5 mm broke off during the drilling/ milling step.The fragment remained in the bone of the patient.Concomitant device reported: unk - bone graft (part # unknown, lot # unknown, quantity 1), unknown guide wire (part # unknown, lot # unknown, quantity 1).This report is for one trephine attachment 12.5mm diameter.This is report 1 of 1 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.H3, h4, h6: a review of the device history record.Device history lot , part: 387.662, lot: 1l10256, manufacturing site: bettlach, release to warehouse date: 06.Sep.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary: picture review: narrative (teeth of trephine broken off) could be verified from provided pictures.Investigation site: cq zuchwil , selected flow: damaged.Visual inspection: the visual inspection of the complained trephine-attachm ø12.5 has shown that the two teeth broken off.The instrument is in a used condition.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.The damages are clearly caused post manufacturing.Document/specification review: the manufacturing specification were reviewed, and this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review has shown that with 1.4112 the correct material was used.The measurements of the hardness after the hardening procedure were between 54.5 ¿ 54.9 hrc also within the specification of 53 - 56 hrc from drawing se_389140.Rev.C.Summary: the received condition of the trephine-attachment is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in september 2018 according to the specification.Based on that and the condition of the item a product related issue can be excluded.Unfortunately we are not able to determine the exact cause which has led to the damage.We only can assume that a mechanical overloading situation, for example metallic contact, has caused the damages.Furthermore we would like to draw your attention to our surgical technique guide use gentle rotational movements to cut into the bone.By the evidence, that the device passed our 100% final inspection before the device left the manufacturing site we confirm that the cause of failure is not due to any manufacturing non-conformance.During the investigation, no manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TREPHINE ATTACHMENT 12.5MM DIAMETER
• Type of Device: TREPHINE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9861388
• MDR Text Key: 193056877
• Report Number: 8030965-2020-02152
• Device Sequence Number: 1
• Product Code: HWK
• UDI-Device Identifier: 07611819245259
• UDI-Public: (01)07611819245259
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 387.662
• Device Lot Number: 1L10256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BONE GRAFT; UNKNOWN GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR