MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	358.696
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.A review of the device history records has been requested.(b)(4).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 that on (b)(6) 2018, during an open reduction internal fixation (orif) surgery for the left humeral diaphyseal fracture was performed with an expert humeral nailing system.The surgeon tried to insert the spiral blade in accordance with the surgical technique but the blade interfered with the anterior side of the nail.This was confirmed by x-ray analysis.The surgeon removed the blade from the patient and found it was broken.Another blade of different length was inserted successfully by adjusting the inserter to face the anterior within the aiming arm.The surgery was delayed less than 30 minutes.Adverse consequence was not reported.This report is for one (1) spiral blade inserter for ti humeral nails.This is report 3 of 4 for (b)(4).
Additional 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.A device history record (dhr) review was conducted: part: 358.696 lot: 2477075 manufacturing site: bettlach release to warehouse date: 29.Apr.2009 the device history record shows this lot of 23 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: the visual inspection of the complained inserter shows that this instrument is still in good condition even it is rather old and often used.Functional test: the inserter could be passed through the aiming arm as intended with no problem and fits properly with the hole.The received condition of the instrument does not agree with the complaint description.However, as the received spiral blade shows signs of contact with the used nail, we can understand that there have been problems while insertion.Usually pressure from soft tissues may have caused misalignment of the system what finally did not allow to pass the blade through the nail as foreseen.From the point of view of this instrument, we classify this complaint as not confirmed.No product problem could be identified.As manufacturing related issue could be excluded, no further investigations are required according to w-m-s080.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: SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8185831
• Report Number: 8030965-2018-59199
• Device Sequence Number: 1437467
• Product Code: LXH
• UDI-Device Identifier: 07611819714823
• UDI-Public: (01)07611819714823
• 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,Followup
• Report Date (Section B): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 358.696
• Device Lot Number: 2477075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR