MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OPAL IMPLANT HOLDER PISTOL GRIP; MISC ORTHO SURGICAL INSTR

Catalog Number	03.803.002
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: visual inspection: the opal impl-holder w/pistol grip (part # 03.803.002 / lot # h550263) was received at us cq.The device appeared to be in good shape.There was no evidence of a physical device breakage.The overall complaint was not confirmed as there was no defect identified with the device.Device failure/defect identified? no; no defect was identified during investigation.Conclusion: the overall complaint was not confirmed for the received opal impl-holder w/pistol grip.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the investigation.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 history: part # 03.803.002, synthes lot # h550263, supplier lot # h550263, release to warehouse date: 09 may 2018, supplier: avalign technologies-nemcomed.No ncr's were generated during production.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported an unknown procedure performed on (b)(6) 2020.It was preoperatively found that only one gripper was attached to the pistol grip.It was not used during the procedure.This is report 1 of 1 (b)(4).

• Brand Name: OPAL IMPLANT HOLDER PISTOL GRIP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9876831
• Report Number: 8030965-2020-02264
• Device Sequence Number: 2952243
• Product Code: LXH
• UDI-Device Identifier: 07611819940604
• UDI-Public: (01)07611819940604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.803.002
• Device Lot Number: H550263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1